Golden Rice Licensing Arrangements

Golden Rice and Intellectual Property

Humanitarian Use Licences

Breeding institutions in developing countries may obtain a licence to use Golden Rice from the Humanitarian Board. Applications should be based on a breeding program as part of which the provitamin A-production trait is to be introgressed (i.e. introduced by conventional breeding) into local varieties. If biosafety regulations are not in place in the target country, consideration must be given to an implementation strategy of a regulatory framework that would allow release of Golden Rice varieties in due time. For more information you may contact Dr Adrian Dubock, Golden Rice Project Manager at contact@goldenrice.org.

For technical reasons the Golden Rice versions donated for humanitarian use were in North American varieties of the javanica type. The first generation of Golden Rice went into the variety 'Cocodrie', while the latest was generated in a variety called 'Kaybonnet'. Selected transgenic events containing the provitamin A-production trait have been introgressed into local varieties in the Philippines, India, Vietnam, and Bangladesh.

After four to six rounds of backcrossing the local parental line is fully recovered, with the only difference that it is now capable of producing and accumulating beta-carotene (provitamin A). There is no limit to how many locally adapted varieties can be produced in this way. All depends on when the lengthy and expensive regulatory process will have been completed.

Public-Private Partnership and Humanitarian Use

Free access for those who need it

Patents are tools to protect commercial interests and investments, but as the Golden Rice example clearly shows, they are not an impediment to the use and dissemination of a technology among poor people. Apart from being national in scope and limited in time, patent owners can decide to whom to license and under what terms. Notwithstanding the fact that a number of patented technologies were involved in the production of Golden Rice (Kryder et al. 2000), Syngenta Seeds AG was able to negotiate access to all pieces of the puzzle for humanitarian use and to provide the Golden Rice Humanitarian Board with the right to sublicense the technology to breeding institutions in developing countries, free of charge.

The patented key technology for the generation of Golden Rice, invented by emeritus professor Ingo Potrykus, of the Swiss Federal Institute of Technology Zurich (ETH Zurich), and Prof Peter Beyer, of the Univ of Freiburg, was the bargaining chip that provided access to a package of ancillary technologies needed to engineer the trait into rice (e.g. genetic transformation techniques and gene construct elements). A licence to those technologies was obtained from Syngenta. The package contained proprietary technologies belonging not only to Syngenta but also to Bayer AG, Monsanto Co, Orynova BV, and Zeneca Mogen BV.These companies provided access to the required technologies free of charge, for humanitarian purposes.

The licensing process was quick and simple, contrary to what many onlookers believe. Similar projects are looking at this licensing agreement as a good example of how humanitarian issues can be efficiently addressed using this kind of arrangement between the public and private sectors.

The heading of the PCT patent application representing the IP cornerstone of the Golden Rice Project. This one patent opened the door to a larger technology package.

Independent claims of Australian patent AU776160B2 issued to the Golden Rice inventors Ingo Potrykus and Peter Beyer. Independent claims define the scope of the patent in the broadest terms.

Title of the patent: Method for improving the agronomic and nutritional value of plants

CLAIMS

1. A method of producing plant cells that accumulate carotenoids which cells are normally carotenoid-free, said method comprising transforming plant material with an isolated DNA molecule comprising a nucleotide sequence which comprises:

(a) an expression cassette capable of directing production in said cells of a phytoene synthase derived from a plant, a fungi or a bacteria; and

(b) an expresion cassette capable of directing production in said cells of phytoene desaturase derived from a plant, a fungi or a bacteria wherein when said phytoene desaturase is derived from a bacteria said phytoene synthase is not derived from a bacteria

(a) an expression cassette capable of directing production in said cells of a phytoene synthase derived from a plant; and

(b) an expression cassette capable of directing production in said cells of a phytoene desaturase derived from a bacteria.

The Basics of the Licensing Agreement between Syngenta and the inventors of Golden Rice

Universities are usually not in the business of developing products. From the onset of the Golden RiceProject it was clear that in case the project was successful, a product should be developed, and that this product would have to reach vitamin A-deficient people in developing countries. That means, it had to be a humanitarian project.

Industries are in the business of develop and selling products. Thus, an industrial partner was sought that would agree to the humanitarian use of a product derived from the invention, apart from a commercial use. Such a partner was found with Syngenta, an agrichemicals and seeds company with headquarters in Switzerland. Syngenta was instrumental in converting the proof-of-concept results generated at the University of Freiburg and ETH Zurich into deliverable products. The collaboration was based on the understanding that Syngenta would retain commercial exclusivity for the technology, including large agricultural setups in developing countries while allowing its humanitarian use free of charge.

In 2005 Syngenta decided not to go commercial with Golden Rice in developed countries, a main reason being that there is practically no vitamin A deficiency in such countries. and thus very little commercial interest, even though antioxidants are very fashionable, and provitamin A is such an antioxidant.

The essence of the Sublicensing Agreement

The inventors have assigned their exclusive rights to the Golden Rice technology to Syngenta.

Syngenta negotiated licences with other companies to use a number of ancillary technologies, needed to create Golden Rice.

Syngenta, in turn, has given the inventors a humanitarian licence to the full set of necessary technologies with the right to sublicense public research institutions and low-income farmers in developing countries, .

Syngenta retains commercial rights, although it has abandonned its plans to commercialise Golden Rice.

"Humanitarian Use" means (and includes research leading to):

Use in developing countries (low-income, food-deficit countries as defined by FAO)

Resource-poor farmer use (earning less than US$10,000 per year from farming)

The technology must be introduced into public germplasm only.

No surcharge may be charged for the technology (i.e. the seed may cost only as much as a seed without the trait)

National sales are allowed by low-income farmers (in this way urban needs are also covered)

Reusing the harvested grain as seed for the following season is allowed (the farmer is the owner of his seeds

Regulatory imperative and national sovereignty, i.e. Golden Rice may not be released in a country lacking biosafety regulations, and the decision to adopt the technology is a national matter.

No export allowed (except for research to other licensees): this is a humanitarian project, i.e. the seeds are meant to cover the daily requirements of the poor that are deficient in vitamin A.

Improvements to licensed technology:

Commercial rights of improvements to the technology go to Syngenta, but

Humanitarian Use of such improvements is guaranteed under the same terms of the original agreement (in this way any improvements to the technology will serve the humanitarian purpose).

No warranties are given by licensor(s) (this is related to the fact that every receiving country will determine what biosafety and agronomic requirements to impose before approval of a Golden Rice variety.

Liabilities and costs &emdash; each party is responsible for what it controls (this follows also from the fact that this is a humanitarian project and not a commercial enterprise).

Selection of locally adapted varieties as receptors of the provitamin A-producing trait:

While countries that adopt the technology are free to introduce the trait into their preferred varieties, there are some criteria on which strategic decisions for selection should be based. For example, receptor varieties should be preferably widely used by farmers. Those varieties should also be expected to maintain prominence over time and be grown by the most productive farmers in vitamin A deficiency-prone regions (for local and regional supply).

Missed opportunities

Many people are ready to get involved, yet policymakers have been too often ill advised

The need to obtain gene constructs and transgenic traits directly from multinational companies is often brought up and seen as a hindrance to the adoption of biotechnological crops by developing countries, and moreover, as unaffordable for small-scale farmers.

There is no prima facie reason why transgenic crop should be only available from company sources, who are primarily accountable to their investors. Public sector institutions and scientists can also create de novo products using the same tools. But for the public sector, the financial means to deal with the regulatory process is beyond grasp.

Developing countries can take advantage of the patent system itself. Patents are not international in scope. Most patents are sought only in a few developed countries, where the owner expects to conduct business using the protected invention. Another aspect of patenting, is that patents expire after 20 years from filing. Many biotechnological inventions have already come off patent already or are in the process becoming public as we speak.

Even if patents appear to be still in place, there may be grounds to invalidate the patent in question, which of course would be for the courts to decide.

Why is the public sector not doing more to create and develop its own transgenic crops? The reality is that there are hundreds of transgenic events that have been generated by the public sector, a high proportion of those in developing countries, but the great majority has been shelved due to excessive and needless regulations and the attached costs. A proper, science-based regulatory examination could be done for one tenth or less of it costs nowadays to go through the process. Many of these examinations must be repeated in every country where approval is sought, instead of having internationally accepted standards.

In a curious paradox, the suspicion often caused by anti-globalisation activists against GMO crops (but not against foods processed using GM microbes, e.g. cheese or beer) or pharmaceuticals (e.g. insulin and many new drugs) has reinforced an "environmentally justified" set of regulatory hurdles which only large companies can afford. Thus, anti-globalisation campaigners have "shot themselves in the foot", and the farmers and consumers who would benefit from those crops are the collateral victims. There is no scientific justification for these high regulatory costs.

Both conventional and genetic engineering approaches to trait development involve the generation of genome alterations from which breeders then select useful variation for further breeding, while simply culling any breeding line with undesirable traits. All internationally credible scientific institutions have come to the same conclusion: there is no specific health or environmental risk from the techniques used in genetic engineering of crops compared to any other form of crop breeding.

The use of this additional technology to extend the potential of earlier forms of plant breeding should not be denied, especially to the public sector in developing countries. Food security, both for macro and micronutrients, and the agriculture and health needs of the world's population must be considered with greater weight than unproven environmental suspicions. The agriculture and health communities must speak loudly to demand this.

Countries with undernourished people must make their voices heard, such that international treaties, like the Convention on Biological Diversity, take into account the benefits of biotechnology and also include the loss of opportunity to save the lives of millions of children as part of their precautionary approach, and not just unfounded "environmental concerns". Without a change to these instruments, the only route to access the proven benefits of modern biotechnology will remain via the private sector, which as expected will be seeking to make commercial profit.

Once upon a time, it was believed that Golden Rice would be the door opener for transgenic crops. Many years have passed and Golden Rice may soon be in growers' hands, but in the meantime more than 160 milion hectares are being grown around the world, most of them commercial. Wrong activism has done tremendous damage to the humanitarian use of this great technology. Let's hope that with increasing acceptance and the accumulated experience using GM crops around the world, more and more developing countries will find ways to benefit from the many useful traits in the pipeline in the near future and that many children will have access to biofortified rice and other crops.